Journal article Open Access

A REVIEW: REGULATORY REQUIREMENTS OF DRUG MASTER FILE IN CONTEXT TO GHANA

Rushikesh B. Katkar1*, Sunil T. Galatage2, Sandip M. Honmane3, Supriya Darandale4

Drug Master Files are required in most African countries as supporting documents for the registration of drug products. Africa is world’s second fastest growing pharmaceutical market. The CGAR of African Pharmaceutical market is 11.6%. African people suffer from numerous diseases. The local pharmaceutical market is weak and insufficient to meet the demand of such diseased condition and so Africa relies heavily on externally developed and procured drugs. This combination of economic strength and prevalence of diseases is already driving a demand for medicines across Africa. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug’s identity, strength, purity and quality. Ghana and Australia which are consider as highly regulated markets (HRMs). In GHANA, DMF filing was done through New Drug Submission (NDS) for both drugs and biologic products. They use MF terminology for DMF which contain four types of MASTER FILE- ASMFs, CCS MFs, Excipient MFs, Drug product MFs. In AUSTRALIA different application processes and regulatory requirements apply depending on the type of therapeutic goods that is applied. They consist of eight phase for DMF registration. Where EU guidelines adopted in Australia include references to EU legislation. Now from 2018 onwards most of the regulated countries will use eCTD or their electronic format for their DMF submission.

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